Actively Recruiting
Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Led by Theodoros Foukakis · Updated on 2025-03-05
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
T
Theodoros Foukakis
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center prospective observational cohort study that aims to: * examine and identify possible risk and susceptibility factors for the incidence and progression of chemotherapy-induced polyneuropathy (CIPN) in female patients primarily operated for early non-metastatic breast cancer who will receive adjuvant chemotherapy containing paclitaxel * test different neurophysiological methods for early detection of CIPN * explore changes that underlie the development of CIPN in relation to clinical presentations, neurophysiological assessment, including measures of small nerve fiber dysfunction, and possible biochemical, metabolic and genetic associations * explore the effects of CIPN in the patient's lifestyle and quality of life for up to 12 months after the initiation of treatment
CONDITIONS
Official Title
Paclitaxel-induced Polyneuropathy in Breast Cancer: Early Detection, Risk Factors, Quality of Life and Lifestyle Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients
- Age of ≥ 18 years
- Newly operated primary breast cancer without metastatic disease receiving adjuvant chemotherapy containing paclitaxel
- No prior chemotherapy other than cyclophosphamide and epirubicin
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Written informed consent
- Able to communicate with investigators, participate in testing and comply with the requirements of the study-protocol
You will not qualify if you...
- Have received drugs suspected/known to cause peripheral neuropathy
- Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy
- Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance
- Have moderate to severe kidney, liver, lung or heart disease
- Have known symptomatic or other advanced spinal stenosis
- Have known autoimmune disease that potentially cause or contribute to neuropathy
- Have known HIV or active HBV or HCV infections
- Have known paraneoplastic syndrome
- Have known alcohol abuse
- Have known pregnancy or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Solna, Stockholm County, Sweden, 171 76
Actively Recruiting
Research Team
T
Theodoros Foukakis, MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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